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510(k) K100230

SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V by Eleme Medical, Inc. — Product Code NUV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
January 26, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Light Induced Heating
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended to temporarily alter the appearance of cellulite

Other clearances by Eleme Medical, Inc.

  • K083478 — SMOOTHLIPO (March 17, 2009)
  • K083629 — SMOOTHSHAPES (February 19, 2009)

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  • K101366 — I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) (September 17, 2010)
  • K092195 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (October 1, 2009)
  • K090221 — REACTION SYSTEM (July 1, 2009)